Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Provides project-related support to the Program, Senior, and Project Manager(s) and other project team members from proposal development through final deliverable.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Manages projects of limited scope (functional or regional). Responsible for project team leadership.
- Responsible for building and maintaining positive client relationships
- Ability to negotiate with clients to assure Novella's operational processes are maintained, projects are done within scope
- Reviewing and identifying project study trends and proactively responding to client and respective team members
- Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
- Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements
- Responsible for change management on all assigned projects
- Responsible for assuring projects assigned are run according to SOPs and WP as defined in the scope of work
- Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead
- Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware
- In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.
- Oversee delegation of support staff activities, as necessary
- Assists in the development and delivery of capability and proposal defense presentations to prospective clients
- Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team.
- Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually
- Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
- Responsible to maintain personal currency documentation for Novella SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of office
- May support Director, Project Management, and Project Management team as required by providing appropriate staff management for awarded programs.
- Supports Project or Program Managers with directional insight for Change Orders and Out of Scope work; Assists in communication of budget allocations and approval of invoices.
- Responsible for supporting Project Managers/Program Managers thorough management of project timelines. Assist/Manage in the development of project timelines and milestone tracking.
- Through matrix reporting, responsible for supporting project teams both administratively and technically as appropriate.
- Participates and assists in the planning and creation of client and investigator meetings and related materials.
- Authorized to:
- Approve project and pass-thru expenditures up to $25,000.00
- Performs other duties as required.
KNOWLEDGE, SKILLS AND ABILITIES:
- Good knowledge of clinical research process
- Excellent organizational and interpersonal skills
- Ability to work independently, prioritize and work with in a matrix team environment required.
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
- Ability to handle multiple priorities within multiple, complex clinical trials
- Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research
- Extensive working experience with Microsoft Word, Excel, and Power Point
- Strong communication skills (verbal and written) to express complex ideas
- Ability to set baseline targets, track trends and implement mitigation plans
- Working knowledge of current ICH GCP guidelines
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very limited physical effort required to perform normal job duties.
- Travel may be required, including international travel
- Must be able to secure a credit card cosigned by Novella
MINIMUM RECRUITMENT STANDARDS:
- AAS/BS/BA and a minimum of two (2) years related clinical research experience preferred
- Minimum one (1) year management experience
- Experience in contract/timeline management preferred
- Excellent written and verbal communication skills required
US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
Job ID: R1059202